ALE.P03 for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the optimal dose of ALE.P03, a new treatment, and assess its safety and effectiveness for individuals with certain advanced cancers, such as colorectal cancer. The study will test various doses to identify the safest and most effective one for future treatment stages. Participants should have specific advanced cancers and have previously tried standard treatments that were not effective. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that ALE.P03 is likely to be safe for humans?
Research is investigating ALE.P03 to determine its safety and tolerability in certain cancers, including colorectal cancer. As the trial is in its early stages, the primary goal is to establish a safe dose and monitor for side effects.
Researchers closely monitor participants for any adverse reactions during these initial trials. If ALE.P03 proves unsafe, the study will not proceed. So far, it appears to be tolerated well enough for further research. However, detailed safety information is not yet available due to the study's early phase. Participants in this trial will help assess ALE.P03's safety for future use.12345Why do researchers think this study treatment might be promising for colorectal cancer?
Researchers are excited about ALE.P03 for colorectal cancer because it offers a novel approach compared to standard treatments like chemotherapy or targeted therapies. ALE.P03 is unique because it is administered as a monotherapy via intravenous infusion and aims to identify the maximum tolerated dose and safe recommended dose, potentially minimizing side effects and enhancing patient outcomes. Additionally, its distinct mechanism of action could pave the way for more personalized and effective treatment options, addressing the limitations of current therapies.
What evidence suggests that ALE.P03 might be an effective treatment for colorectal cancer?
Research shows that ALE.P03 targets claudin-1, a protein often found in certain solid tumors. This treatment attaches to cancer cells and destroys them. Studies have shown that ALE.P03 can effectively shrink tumors with claudin-1. Early results suggest it works well, especially in colorectal cancer. In this trial, participants will receive ALE.P03 as monotherapy in different phases to determine the optimal dosing. This treatment might also enhance the effectiveness of other treatments, like immunotherapy, making ALE.P03 a promising option for patients with these types of tumors.12346
Are You a Good Fit for This Trial?
This trial is for adults with certain advanced or metastatic solid tumors that test positive for CLDN1. These cancers include colorectal, bile duct, transitional cell carcinoma (often found in the bladder), cervical, lung, and liver cancers.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I Dose Escalation
Patients receive ALE.P03 as monotherapy via intravenous infusion at escalating doses to determine the maximum tolerated dose and recommended dose for expansion
Phase I Dose Expansion
Patients receive ALE.P03 at the recommended dose for expansion to identify the recommended Phase II dose
Phase II
Patients receive ALE.P03 at the recommended Phase II dose to evaluate anti-tumor activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ALE.P03
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alentis Therapeutics AG
Lead Sponsor